SUBSCRIBE
SUBSCRIBE

Government

FDA
BMS’ Opdivo and Yervoy Combination Treatment Snags Two Approvals in Lung Cancer this Month
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
May 27, 2020
 · 
2 min read
 · 
Alex Keown
FDA
Sanofi and Regeneron’s Dupixent Scores Another Approval for Dermatitis, This Time in Kids
To date, Dupixent is the only biologic approved for this age group.
May 26, 2020
 · 
3 min read
 · 
Mark Terry
Lumasiran was granted priority review status by FD
Policy
FDA Grants Priority Review to Alnylam’s RNAi Therapy Lumasiran for Primary Hyperoxaluria Type 1
Alnylam Pharmaceuticals’ lumasiran for a chronic kidney stone disease was granted Priority Review status by the U.S. Food and Drug Administration. It will have a target action date of December 3, 2020.
May 26, 2020
 · 
3 min read
 · 
Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 26
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
May 26, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
FDA Action Alert: Evofem, Sanofi, Regeneron and Incyte
Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration has a number of drug approvals on the calendar. Here’s a look.
May 22, 2020
 · 
3 min read
 · 
Mark Terry
Kynmobi got approved stamp from FDA
FDA
FDA Gives Thumbs-Up to Sunovion’s Under-the-Tongue Parkinson’s Drug Kynmobi
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
May 22, 2020
 · 
3 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 22
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
May 22, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 21
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
May 21, 2020
 · 
4 min read
 · 
BioSpace Editorial Staff
Policy
U.S. Government Provides AstraZeneca More Than $1 Billion for COVID-19 Vaccine
The U.S. Biomedical Advanced Research and Development Authority (BARDA) paid more than $1 billion to support the development, production and delivery of the vaccine beginning this fall.
May 21, 2020
 · 
7 min read
 · 
Mark Terry
Policy
Biopharma Update on the Novel Coronavirus: May 20
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
May 20, 2020
 · 
6 min read
 · 
BioSpace Editorial Staff
Load More
PRESS RELEASES
Business
Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s approval of Dsuvia and the FDA’s future consideration of new opioids
November 2, 2018
 · 
11 min read
Policy
Public Health Notice - Outbreak of Salmonella infections possibly linked to long English cucumbers
November 2, 2018
 · 
5 min read
Business
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s continued efforts to address growing epidemic of youth e-cigarette use, including potential new therapies to support cessation
November 2, 2018
 · 
5 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., on findings from the romaine lettuce E. coli O157:H7 outbreak investigation and FDA’s efforts to prevent future outbreaks
November 1, 2018
 · 
7 min read
Policy
Statement from Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health on the National Toxicology Program’s report on radiofrequency energy exposure
November 1, 2018
 · 
5 min read
Policy
Medicare Open Enrollment is here
November 1, 2018
 · 
2 min read
Policy
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health and Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research
November 1, 2018
 · 
5 min read
Policy
Healthcare Experts Propose Both Market and Regulatory Changes to Reduce Prescription Drug Costs Amid the Trump Administration’s Call to Cut Medicare Drug Prices
November 1, 2018
 · 
3 min read
Policy
Medacta Unveils Two New Kinematic Alignment Options for Knee Replacement Surgery
November 1, 2018
 · 
4 min read
Business
Notice to the media - Minister of Health, Chief Public Health Officer, Mayor of Ottawa and Medical Officer of Health of Ottawa to host pop-up flu shot booth for media
October 31, 2018
 · 
1 min read
Policy
Pharma Logistics Announces New DOD OCONUS, VA and Other Government Business
October 31, 2018
 · 
1 min read
Business
Statement - Minister Goodale welcomes the Office of the Correctional Investigator’s Annual Report
October 30, 2018
 · 
1 min read
Business
Johnson & Johnson Innovation Launches Reimagining Respiratory Protection QuickFire Challenge in Collaboration with the U.S. Department of Health and Human Services
October 30, 2018
 · 
6 min read
Policy
FDA takes action to stop the use of lead acetate in hair dyes
October 30, 2018
 · 
3 min read
Policy
Public Health Notice - Outbreaks of Salmonella infections linked to raw chicken, including frozen raw breaded chicken
October 26, 2018
 · 
8 min read
Policy
Government of Canada proposes new regulations to support Canadians who use reproductive technologies
October 26, 2018
 · 
2 min read
Policy
/R E P E A T -- Media Advisory: Press Conference - Sherman Family Investigative Team Provides Update on Double Homicide/
October 26, 2018
 · 
1 min read
Policy
Proposed Change in Definition of Gender Threatens Transgender Community
October 25, 2018
 · 
2 min read
Policy
Notice to the media - Health Canada to hold a media technical briefing on the Assisted Human Reproduction Act
October 25, 2018
 · 
1 min read
Policy
Information Update - Staying Safe on Halloween
October 25, 2018
 · 
2 min read
Load More